Endobronchial diagnostic systems and methods

Abstract

A method and system for accessing and diagnosing a diseased lung segment is disclosed. The method includes the steps of introducing a diagnostic catheter having an occlusion member at its distal end into a lung segment, inflating the occlusion member to isolate the lung segment, and performing a diagnostic procedure with the diagnostic catheter. The proximal end of the diagnostic catheter is configured to be attached to a console. The method may further include using a unidirectional flow element within or in line with the catheter passageway to allow flow in a proximal-to-distal direction or inhibit or block flow in a distal-to-proximal direction, thereby allowing air to enter the lung segment through the passageway in the catheter during patient inspiration and inhibiting air from escaping through the catheter passageway during patient expiration.

Description

[Technical Field]

[0001] [Citation of Related Applications] This application is a claim of U.S. Provisional Patent Application No. 63 / 050,312, filed July 10, 2020 (Attorney Docket No. 20920-778.101), which is incorporated by reference in its entirety.

[0002] The present invention relates generally to methods for diagnosing and treating pulmonary diseases. [Background technology]

[0003] Chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis, is a serious medical problem currently affecting approximately 16 million people in the United States alone (approximately 6% of the U.S. population). Two types of diagnostic tests are generally performed on patients to determine the extent and severity of COPD: 1) imaging tests and 2) functional tests. Imaging tests, such as chest x-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI) images, perfusion scans, and bronchograms, provide a good indication of the location, homogeneity, and progression of diseased tissue. However, imaging tests do not provide a direct indication of how the disease is affecting a patient's overall lung function and breathing. Pulmonary function can be well assessed using functional tests, such as spirometry, plethysmography, oxygen saturation, and oxygen consumption stress tests, among others. These imaging and functional diagnostic tests are used together to determine a patient's treatment path.

[0004] One emerging treatment for COPD involves endoscopically introducing an endobronchial occluder or one-way valve device (an "endobronchial valve," or "EBV") into the pulmonary passageways to reduce the volume of one or more hyperinflated lung compartments, thus creating a healthy compartment with more breathing space and potentially reducing pressure on the heart. Examples of such methods and implants are described, for example, in U.S. Patent Application No. 11 / 682,986 and U.S. Patent No. 7,798,147, which are incorporated by reference in their entireties. One-way valves implanted in the airways leading to a lung compartment restrict airflow in the inspiratory direction and allow air to exit the lung compartment during exhalation, thereby allowing adjacent lung compartments to collapse over time. The occluder blocks both inspiration and expiration, which also leads to lung collapse over time.

[0005] It has been suggested that the use of lung volume reduction implants may be most effective when applied to lung compartments not affected by collateral ventilation. Collateral ventilation occurs when air flows from one lung compartment to another through collateral pathways rather than the primary airway pathway. If collateral airflow pathways exist within a lung compartment, implanting a one-way valve or occluder may be ineffective, as the compartment may continue to fill with air from the collateral source and thus not collapse as intended. COPD often manifests as the creation of multiple collateral pathways caused by alveolar rupture or destruction and weakening of alveolar tissue due to hyperinflation.

[0006] A commonly used endobronchial catheter-based diagnostic system for measuring collateral ventilation is disclosed in U.S. Patent Application Publication No. 2003 / 0051733 (which is incorporated by reference herein in its entirety), in which a catheter isolates a lung compartment using an occlusion, and instrumentation is used to collect data, such as changes in inspiratory / expiratory pressure and volume. Methods for measuring collateral ventilation are disclosed in U.S. Patent Application Publications Nos. 2008 / 0027343, 2014 / 0336484, and 2007 / 0142742 (all of which are incorporated by reference herein in their entireties), in which an isolation catheter is used to isolate a target lung compartment and pressure changes within the target lung compartment are sensed to detect the extent of collateral ventilation. These publications also disclose methods for measuring gas concentrations to determine the efficiency of gas exchange within the lung compartment. A similar method is disclosed in International Application Publication No. WO 2009 / 135070(A1), which is incorporated herein by reference in its entirety, in which collateral ventilation can be determined by changes in gas concentration in a segment of the lung isolated by a catheter.

[0007] Quantifying collateral ventilation through collateral resistance measurement and calculation typically requires approximately 2–5 minutes. During this time, the physician must ensure the patient tolerates sedation, manage secretions to prevent obstruction within the catheter lumen, and maintain the balloon seal / position within the target airway. Any one of these factors can prolong the assessment time and potentially compromise the results. Thus, there is a need for a faster and more efficient way to quantify the magnitude of collateral ventilation within lung compartments (e.g., lobes, segments, subsegments). [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent Application Serial No. 11 / 682,986 [Patent Document 2] U.S. Patent No. 7,798,147 [Patent Document 3] US Patent Application Publication No. 2003 / 0051733 [Patent Document 4] U.S. Patent No. 7,883,471 [Patent Document 5] US Patent Application Publication No. 2008 / 0027343 [Patent Document 6] US Patent Application Publication No. 2014 / 0336484 [Patent Document 7] US Patent Application Publication No. 2007 / 0142742 [Patent Document 8] International Application Publication No. WO2009 / 135070(A1) Pamphlet Summary of the Invention [Problem to be solved by the invention]

[0009] It would therefore be advantageous to provide novel diagnostic techniques for assessing pulmonary disease progression, for example, to determine the presence and degree of collateral ventilation. At least some of these objectives are achieved by the embodiments described herein. [Means for solving the problem]

[0010] This application discloses a method and system for assessing the function of a patient's lung compartment. In one aspect, the method for assessing the function of a patient's lung compartment includes introducing a diagnostic catheter into the lung compartment, inflating an obstruction member to isolate the lung compartment, measuring CO2 concentration in the isolated lung compartment over time, and determining whether collateral ventilation is occurring in the isolated lung compartment based on the measured CO2 concentration over time in the isolated lung compartment. The proximal end of the diagnostic catheter is configured to be attached to a console, and data from the diagnostic procedure can be displayed on the console. In one embodiment, collateral ventilation can be determined to be occurring in the isolated lung compartment if the CO2 concentration in the isolated lung compartment fluctuates with breathing. Collateral ventilation can be determined not to be occurring in the isolated lung compartment if the CO2 concentration in the isolated lung compartment remains stable over time. In one embodiment, the degree of collateral ventilation can be determined based on the slopes of different regions of a CO2 concentration curve.

[0011] In another aspect, a method for assessing the function of a patient's lung compartment includes introducing a diagnostic catheter into the lung compartment, inflating an obstruction member to isolate the lung compartment, measuring the O concentration in the isolated lung compartment over time, and determining whether collateral ventilation is occurring in the isolated lung compartment based on the measured CO concentration over time in the isolated lung compartment. The proximal end of the diagnostic catheter is configured to be attached to a console, and data from the diagnostic procedure can be displayed on the console. In one embodiment, collateral ventilation can be determined to be occurring in the isolated lung compartment if the O concentration in the isolated lung compartment levels off above a threshold. Collateral ventilation can be determined not to be occurring in the isolated lung compartment if the O concentration in the isolated lung compartment levels off below a threshold. In one embodiment, the degree of collateral ventilation can be determined based on the rate of decrease in O concentration in the isolated lung compartment after isolation. Optionally, these methods can be performed while the patient is being ventilated with an assisted ventilation device with elevated O concentration in the air.

[0012] In yet another aspect, a method for assessing the function of a patient's lung compartment includes sealing a distal end of a catheter within an airway supplying the lung compartment with an obstruction member adapted to inflate within the airway so that access to the lung compartment is only possible through a passage in the catheter when the obstruction member is inflated; allowing air to enter the lung compartment through a passage in the catheter while the patient is inhaling; preventing air from escaping the lung compartment through the catheter passage while the patient is exhaling by using a unidirectional flow element adapted to allow flow in a proximal-to-distal direction or prohibit or block flow in a distal-to-proximal direction while measuring flow into the lung compartment; and determining whether collateral ventilation is occurring within the lung compartment based on the measured flow into the lung compartment. In one embodiment, collateral ventilation may be determined to be absent if flow into the lung compartment decreases below a threshold value. Collateral ventilation may be determined to be occurring if flow into the lung compartment remains above the threshold value. In one embodiment, collateral ventilation may be determined based on measured flow into the lung compartment.

[0013] In another aspect, a method for assessing the function of a patient's lung compartment includes the steps of sealing a distal end of a catheter in an airway supplying the lung compartment by using an obstruction element adapted to inflate in the airway supplying the lung compartment so that access to the lung compartment is only possible through a passage in the catheter when the obstruction element is inflated; allowing air to enter the lung compartment through a passage in the catheter while the patient is inhaling; preventing air from escaping the lung compartment through the catheter passage while the patient is exhaling by using a unidirectional flow element adapted to allow flow in a proximal-to-distal direction or inhibit or block flow in a distal-to-proximal direction while the patient is exhaling; measuring pressure within and flow into the lung compartment; and determining whether collateral ventilation is occurring in the lung compartment based on the measured pressure within the lung compartment. In one embodiment, determining whether collateral ventilation is occurring in the isolated lung compartment includes calculating a value of collateral resistance. The degree of collateral ventilation can be determined based on the calculated value into the lung compartment.

[0014] Further aspects and embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0015] The present embodiments have other advantages and features that will be readily apparent from the following detailed description and appended claims, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 illustrates a diagnostic or evaluation catheter for use in the disclosed methods according to some embodiments of the present invention. [Figure 2] FIG. 2 shows the catheter shown in FIG. 1 positioned within the lung. [Figure 3] FIG. 2 illustrates a console configured to receive the catheter shown in FIG. 1. [Figure 4A]1 is a flow chart illustrating one embodiment of the present invention. [Figure 4B] FIG. 4B is a graph showing CO2 concentration without collateral ventilation using the method of FIG. 4A. [Figure 4C] FIG. 4B is a graph showing CO2 concentrations at which collateral ventilation occurs using the method of FIG. 4A. [Figure 5A] 1 is a flow chart illustrating one embodiment of the present invention. [Figure 5B] FIG. 5B is a graph showing O2 concentration without collateral ventilation using the method of FIG. 5A. [Figure 5C] FIG. 5B is a graph showing O2 concentrations at which collateral ventilation occurs by using the method of FIG. 5A. [Figure 6] 1 is a flow chart illustrating one embodiment of the present invention. [Figure 7] 1 is a flow chart illustrating one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0017] While the detailed description contains many details, these details should not be construed as limiting the scope of the invention, but merely as illustrating different examples and different aspects of the present disclosure. It should be understood that the scope of the invention includes other aspects and other embodiments not described herein. Other modifications, changes, and variations apparent to various skilled artisans can be made in the arrangement, operation, and details of the methods, apparatus, and systems according to the aspects and embodiments disclosed herein without departing from the spirit and scope of the invention as described herein.

[0018] Throughout this specification and patent applications, the following terms have the meanings expressly associated therewith unless the context clearly dictates otherwise. In the original specification, the singular forms "a," "an," and "the" include the plural by definition. In the original specification, "in" (often translated as "inside") includes the plural by definition. With reference to the drawings, like numerals refer to like parts throughout the figures. Additionally, when the singular is used, it includes the plural unless otherwise specified or inconsistent with the disclosure herein.

[0019] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as advantageous over other embodiments.

[0020] The present application provides methods and systems for targeting, accessing, and diagnosing diseased lung compartments. Such compartments may be entire lobes, segments, subsegments, or any other portion of the lung. Diagnosis is achieved in the disclosed embodiments by isolating the lung compartment and obtaining various measurements to determine lung function. While COPD is used as an example, the industrial applicability of these methods for treatment and diagnosis is not limited to COPD and can be applied to any lung disease.

[0021] Such methods are minimally invasive in the sense that the necessary instruments are introduced through the mouth, tracheotomy, or other site, typically via a bronchoscope, assisted ventilation device, or other non-surgical device passed through the mouth and into the trachea and airways. In some embodiments, the patient is allowed to breathe normally during the procedure. Some embodiments may be used in conjunction with assisted (or positive pressure) ventilation. Such methods detect the presence or characteristics (e.g., concentration or pressure) of one or more naturally occurring or introduced gases to determine the presence or absence of collateral ventilation and / or measure one or more other characteristics of the targeted lung compartment, such as tissue oxygen saturation.

[0022] For some of the present embodiments, pulmonary isolation involves sealing the distal end of a catheter within the airway supplying the lung compartment, as shown in Figures 1 and 2. Such a catheter is disclosed in published U.S. patent application Ser. No. 10 / 241,733, the disclosure of which is incorporated herein by reference. As shown in Figure 1, a catheter 100 includes a catheter body 110 and an expandable occlusion member 120 disposed on the catheter body. The catheter body 110 has a distal end 102, a proximal end 101, and at least one lumen 130 extending from a location at or near the distal end to a location at or near the proximal end.

[0023] The proximal end of the catheter 100 is configured to couple to an external control unit (or "console" (not shown)) and optionally includes an inflation port (not shown). The distal end of the catheter 100 is adapted to be advanced through a body passageway, such as a pulmonary airway. An expandable occlusion member 120 is provided near the distal end of the catheter body, and the occlusion member is adapted to expand within the airway supplying the target lung compartment. In one embodiment, the occlusion member 120 is a flexible balloon made of a transparent material. The transparent material allows visualization through the balloon using a bronchoscope. The occlusion member 120 is inflatable with a syringe configured to couple to the inflation port. Optionally, the catheter 100 includes visual markers at the proximal and distal ends of the balloon to identify the location of the occlusion member 120 within the airway prior to inflation. The material of occlusion member 120 inflates and seals at inflation pressures of 5-20 psi to prevent balloon movement within the airway. This inflation pressure also helps occlusion member 120 maintain a symmetrical configuration within the airway, thereby ensuring that the catheter (which is centered within occlusion member 120) remains centered within the airway. The material and attachment of occlusion member 120 are also configured to minimize longitudinal movement of occlusion member 120 relative to the catheter body 110 itself. To accommodate high inflation pressures, occlusion member 120 is made of polyurethane, such as Pellethane 80A, but may be made of any material that maintains structural integrity at high inflation pressures.

[0024] Additionally and optionally, the catheter 100 further includes at least one sensor 140 located within or in line with the lumen 130 to detect various gas characteristics in the air delivered to or received from the lung compartment. The sensor may be any suitable sensor, or any combination of suitable sensors, configured to communicate with the control unit 200. Examples of sensors include pressure sensors, temperature sensors, airflow sensors, oxygen sensors, carbon dioxide sensors, gas-specific sensors, or other types of sensors. As shown in FIG. 1 , the sensor 140 may be located near the distal end 102 of the catheter 100. Alternatively, the sensor 140 may be located at any one or more points along the catheter 100 or in line with the catheter 100 and within a control unit that includes one or more measurement components.

[0025] In some embodiments, the system includes a unidirectional flow element disposed within or in line with lumen 130. Examples of unidirectional flow elements are described in U.S. Patent Application No. 15 / 358,483, the disclosure of which is incorporated by reference herein in its entirety. The unidirectional flow element may be configured to allow flow from the isolated lung compartment in a distal-to-proximal direction, but to block or inhibit flow back into the lung compartment in a proximal-to-distal direction. Alternatively, the unidirectional flow element may be configured to allow flow in a proximal-to-distal direction and to block or inhibit flow in a distal-to-proximal direction.

[0026] As shown in FIG. 2 , at least a distal portion of the catheter body 110 is adapted to be advanced into and through the trachea (T). The catheter may optionally be introduced through or on an introducing device, such as a bronchoscope. The distal end 102 of the catheter body 110 may then be directed into a lung lobe (LL) to reach an airway (AW) supplying a target lung compartment (TLC) to be evaluated. When the obstructing member 120 is expanded within the airway, the corresponding compartment is isolated and access to the compartment is provided through the lumen 130.

[0027] The proximal end of the catheter 100 is configured to couple to a control unit (or "console") 200, as shown in FIG. 3. The control unit 200 includes one or more measurement components (not shown) for measuring pulmonary function. The measurement components can take many forms and perform a variety of functions. For example, such measurement components can include a pulmonary mechanics unit, a physiological testing unit, a gas dilution unit, an imaging unit, a mapping unit, a therapy unit, a pulse oximetry unit, or any other suitable unit. These components can be provided within the control unit 200 or attached to the unit 200 from an external source. The control unit 200 includes an interface for receiving input from a user and a display screen 210. The display screen 210 can optionally be a touch-sensitive screen, which can display preset values. Optionally, the user inputs information into the control unit 200 via the touch-sensitive screen mechanism. Additionally and optionally, the control unit 200 can be associated with an external display device, such as a printer or chart recorder. At least some of the system embodiments described above are utilized in the manner described below.

[0028] FIG. 4A is a flow chart illustrating one embodiment for assessing the function of a patient's lung compartment by measuring CO2 within the lung compartment. FIG. 4B illustrates the CO2 concentration without collateral ventilation using the method of FIG. 4A. FIG. 4C illustrates the CO2 concentration with collateral ventilation using the method of FIG. 4A. In step 401, a diagnostic catheter is introduced into the lung compartment. In step 402, an obstruction member is inflated to isolate the lung compartment. In step 403, the CO2 concentration within the isolated lung compartment is measured over time. In step 404, the system determines whether collateral ventilation is occurring within the isolated lung compartment based on the CO2 concentration measured over time within the isolated lung compartment. As can be seen in FIGS. 4B and 4C, the CO2 concentration rises and falls with breathing before the obstruction member is inflated in step 402. When collateral ventilation is not occurring after the lung compartment is isolated in step 402, as shown in FIG. 4B, no washout of fresh air from the collateral flow path occurs. The CO2 concentration rises and levels off over time. The system may be configured to detect the absence of collateral ventilation based on a plateau in CO2 concentration in the isolated lung segment over time. When collateral ventilation is occurring after the lung segment is isolated in step 402, as shown in FIG. 4C, some washout of fresh air occurs from the collateral flow path. CO2 concentration continues to rise and fall with breathing. The system may be configured to detect collateral ventilation based on fluctuations in CO2 concentration in the isolated lung segment. In one embodiment, the degree of collateral ventilation can be determined based on the slopes of different regions of the CO2 concentration curve after the lung segment is isolated.

[0029] FIG. 5A is a flow chart illustrating one embodiment of the present invention. FIG. 5B illustrates the O2 concentration without collateral ventilation using the method of FIG. 5A. FIG. 5C illustrates the O2 concentration with collateral ventilation using the method of FIG. 5A. In step 501, a diagnostic catheter is introduced into a lung compartment. In step 502, an obstruction member is inflated to isolate the lung compartment. In step 503, the O2 concentration in the isolated lung compartment is measured over time. In step 504, the system determines whether collateral ventilation is occurring in the isolated lung compartment based on the O2 concentration measured over time in the isolated lung compartment. When collateral ventilation is not occurring in the isolated lung compartment after the lung compartment is isolated in step 502, as shown in FIG. 5B, the O2 concentration will continuously decrease as O2 is not replenished by entering the blood. The O2 concentration will fall to approximately deoxygenated blood levels and remain low. The system may be configured to detect the absence of collateral ventilation when the O2 concentration in the isolated lung compartment decreases below a threshold. When collateral ventilation is occurring after a lung compartment is isolated in step 502, as shown in FIG. 5C, the O2 concentration decreases but plateaus or reaches a low level as O2 enters from other compartments through collateral pathways. Eventually, O2 is supplied from adjacent compartments as quickly as it is being used by the target compartment. The system may be configured to detect collateral ventilation when the O2 concentration in the isolated lung compartment plateaus above a threshold. In one embodiment, the degree of collateral ventilation may be determined based on the degree of decrease in O2 concentration in the isolated lung compartment after isolation. A higher O2 concentration value at the plateau indicates a higher degree of collateral ventilation. In one embodiment, the method may be performed while the patient is ventilated with air enriched with O2 via an assisted ventilation system. An elevated O2 concentration may be any concentration greater than 21% of that found in normal air. Various embodiments may use elevated O2 concentrations of approximately 50%, approximately 60%, or approximately 100%.

[0030] FIG. 6 is a flow chart illustrating one embodiment of a method for assessing the function of a patient's lung segment. In step 601, an obstruction adapted to be expanded in the airway supplying the lung segment seals the distal end of a catheter within the airway supplying the lung segment, such that access to the lung segment is only possible through the catheter passageway when the obstruction is expanded. In step 602, air is allowed to enter the lung segment through the catheter passageway while the patient is inhaling. In step 603, air is prevented from leaving the lung segment through the catheter passageway while the patient is exhaling by using a one-way flow element adapted to be positioned within or in line with the catheter passageway, allowing flow in a proximal-to-distal direction and prohibiting or blocking flow in a distal-to-proximal direction. In one embodiment, the one-way flow element is a solenoid valve configured to close during exhalation and open during inhalation. In step 604, flow into the lung segment is measured. In step 605, the system determines whether collateral ventilation is occurring in the isolated lung segment based on the measured flow into the lung segment. The system may be configured to determine that collateral ventilation is not occurring when the flow rate into the lung compartment decreases below a threshold value. The system may also be configured to determine that collateral ventilation is occurring when the flow rate into the lung compartment remains above a threshold value. In one embodiment, the degree of collateral ventilation may be determined based on the measured flow rate into the lung compartment. A baseline flow rate may be determined before activating the unidirectional flow element. The degree of collateral ventilation may be determined based on the difference between the baseline flow rate and the flow rate after activating the unidirectional flow element. A small difference in flow rates indicates a high degree of collateral ventilation. A large difference in flow rates indicates very little collateral ventilation. Such a method may be performed during unassisted breathing or with assisted ventilation.

[0031] FIG. 7 is a flow chart illustrating one embodiment of a method for assessing the function of a patient's lung segment. In step 701, an obstruction element adapted to be expanded within the airway supplying the lung segment is used to seal the distal end of a catheter within the airway supplying the lung segment, such that access to the lung segment is only possible through the catheter passageway when the obstruction element is expanded. In step 702, air is allowed to enter the lung segment through the catheter passageway while the patient is inhaling. In step 703, air is prevented from escaping the lung segment through the catheter passageway while the patient is exhaling by using a one-way flow element adapted to be positioned within or in line with the catheter passageway to allow flow in a proximal-to-distal direction or to prohibit or block flow in a distal-to-proximal direction. In one embodiment, the one-way flow element is a solenoid valve configured to close during exhalation and open during inhalation. In step 704, pressure within the lung segment and flow rate into the lung segment are measured. In step 705, the system determines whether collateral ventilation is occurring within the isolated lung segment based on the measured pressure and flow rate. The step of determining whether collateral ventilation is occurring in the isolated lung compartment includes calculating a value of collateral resistance. The degree of collateral ventilation can be determined based on the calculated value of collateral resistance. Such a method can be performed during unassisted breathing or with assisted ventilation.

[0032] While certain embodiments of the present invention have been described in detail, certain variations and modifications will be apparent to those skilled in the art, including embodiments that do not provide all of the features and advantages described herein. As will be understood by those skilled in the art, the present invention extends beyond the specifically disclosed embodiments to other alternative or additional embodiments and / or uses, and obvious modifications and equivalents thereof. In addition, while many variations have been shown and described in various details, other modifications falling within the scope of the present invention will be readily apparent to those skilled in the art based on this disclosure. Furthermore, various combinations or subcombinations of specific features and aspects of the embodiments can be made and still fall within the scope of the present invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another for the purpose of forming various embodiments of the present invention. Thus, the scope of the invention disclosed herein should not be limited by the specific disclosed embodiments described above. With respect to all of the above-described embodiments, the steps of any method need not be performed sequentially.

Claims

1. 1. An apparatus for assessing pulmonary compartment function in a patient, comprising: a catheter having a distal end and a passageway; an obstruction member for sealing the distal end of the catheter in an airway feeding the lung compartment, the obstruction member being adapted to expand within the airway feeding the lung compartment such that when the obstruction member is expanded, access to the lung compartment is only possible through the passageway in the catheter; and a unidirectional flow element adapted to be positioned within or in alignment with the passageway of the catheter to permit flow in a proximal-to-distal direction or to prohibit or block flow in a distal-to-proximal direction, thereby allowing air to pass through the passageway in the catheter and enter the lung compartment while the patient is inhaling; a unidirectional flow element that inhibits air from exiting the lung compartment through the catheter passageway during exhalation by the patient; measuring means for measuring flow into said lung compartment; determining means for determining whether collateral ventilation is occurring in said lung compartment without ventilatory support based on said measured flow into said lung compartment.

2. 2. The apparatus of claim 1, wherein the determining means is configured to determine that collateral ventilation is not occurring when flow into the lung compartment decreases below a threshold value.

3. 2. The apparatus of claim 1, wherein the determining means is configured to determine that collateral ventilation is occurring if flow into the lung compartment remains above a threshold.

4. 4. The apparatus of claim 3, wherein the determining means is further configured to determine collateral ventilation based on the measured flow into the lung compartment.

5. the measuring means is further configured to measure pressure within the lung compartment; 2. The apparatus of claim 1, wherein the determining means is further configured to determine whether collateral ventilation is occurring in the lung compartment based on the measured pressure.

6. 6. The apparatus of claim 5, wherein the determining means is configured to determine whether collateral ventilation is occurring in the lung compartment by calculating a value of collateral resistance.

7. The device of claim 6 , further configured to determine collateral ventilation based on the calculated value of collateral resistance.

8. The apparatus of claim 1 , wherein the one-way flow element comprises a solenoid valve.

9. The apparatus of claim 8 , further comprising a control unit coupled to the solenoid valve.

10. 10. The device of claim 9, wherein the control unit is configured to close the solenoid valve during exhalation and open the solenoid valve during inhalation.

11. 10. The apparatus of claim 1, wherein the measuring means for measuring flow into the lung compartment includes one or more flow sensors.

12. 1. An apparatus for assessing pulmonary compartment function in a patient, comprising: a catheter having a distal end and a passageway; an obstruction member for sealing the distal end of the catheter in an airway feeding the lung compartment, the obstruction member being adapted to expand within the airway feeding the lung compartment such that when the obstruction member is expanded, access to the lung compartment is only possible through the passageway in the catheter; and a unidirectional flow element adapted to be positioned within or in alignment with the passageway of the catheter to permit flow in a proximal-to-distal direction or to prohibit or block flow in a distal-to-proximal direction, thereby allowing air to pass through the passageway in the catheter and enter the lung compartment while the patient is inhaling; a unidirectional flow element that inhibits air from exiting the lung compartment through the catheter passageway during exhalation by the patient; measuring means for measuring flow and pressure within said lung compartment; determining means for determining whether collateral ventilation is occurring in the lung compartment based on the measured flow and pressure in the lung compartment.

13. 1. An apparatus for assessing pulmonary compartment function in a patient, comprising: a catheter having a distal end and a passageway; an obstruction member for sealing the distal end of the catheter in an airway feeding the lung compartment, the obstruction member being adapted to expand within the airway feeding the lung compartment such that when the obstruction member is expanded, access to the lung compartment is only possible through the passageway in the catheter; and a solenoid valve adapted to be positioned within or in line with the passageway of the catheter to permit proximal-to-distal flow or to prohibit or block distal-to-proximal flow, thereby allowing air to pass through the passageway in the catheter and into the lung compartment while the patient is inhaling; a solenoid valve that prevents air from escaping from the lung compartment through the catheter passageway during exhalation by the patient; a control unit coupled to the solenoid valve, the control unit configured to close the solenoid valve during exhalation and open the solenoid valve during inhalation; one or more flow sensors for measuring flow into the lung compartment; determining means for determining whether collateral ventilation is occurring in said lung compartment without ventilatory support based on said measured flow into said lung compartment.

14. 1. An apparatus for assessing pulmonary compartment function in a patient, comprising: a catheter having a distal end and a passageway; an obstruction member for sealing the distal end of the catheter in an airway feeding the lung compartment, the obstruction member being adapted to expand within the airway feeding the lung compartment such that when the obstruction member is expanded, access to the lung compartment is only possible through the passageway in the catheter; and a unidirectional flow element adapted to be positioned within or in alignment with the passageway of the catheter to permit flow in a proximal-to-distal direction or to prohibit or block flow in a distal-to-proximal direction, thereby allowing air to pass through the passageway in the catheter and enter the lung compartment while the patient is inhaling; a unidirectional flow element that inhibits air from exiting the lung compartment through the catheter passageway during exhalation by the patient; CO in the lung compartment ２ a measuring means for measuring the concentration over time; The measured CO in the lung compartment ２ and determining means for determining whether collateral ventilation is occurring in said lung compartment based on the concentration.

15. The determining means determines the CO ２ 15. The device of claim 14, configured to determine that collateral ventilation is not occurring if the concentration levels off over time.

16. The determining means determines the CO ２ 15. The device of claim 14, configured to determine that collateral ventilation is occurring if the concentration varies with respiration.

17. The determining means is ２ 17. The apparatus of claim 16, further configured to determine collateral ventilation based on slopes of different regions of the concentration curve.

18. 1. An apparatus for assessing pulmonary compartment function in a patient, comprising: a catheter having a distal end and a passageway; an obstruction member for sealing the distal end of the catheter in an airway feeding the lung compartment, the obstruction member being adapted to expand within the airway feeding the lung compartment such that when the obstruction member is expanded, access to the lung compartment is only possible through the passageway in the catheter; and a unidirectional flow element adapted to be positioned within or in alignment with the passageway of the catheter to permit flow in a proximal-to-distal direction or to prohibit or block flow in a distal-to-proximal direction, thereby allowing air to pass through the passageway in the catheter and enter the lung compartment while the patient is inhaling; a unidirectional flow element that inhibits air from exiting the lung compartment through the catheter passageway during exhalation by the patient; O in the lung compartment ２ a measuring means for measuring the concentration over time; The measured O in the lung compartment ２ and determining means for determining whether collateral ventilation is occurring in said lung compartment based on the concentration.

19. The determining means determines the O ２ 20. The device of claim 18, configured to determine that collateral ventilation is not occurring when the concentration decreases below a threshold value.

20. The determining means determines the O ２ 20. The device of claim 18, wherein the device is configured to determine that collateral ventilation is occurring when the concentration levels off above a threshold.

21. The determining means determines whether or not O2 in the lung compartment is ２ 21. The device of claim 20, further configured to determine collateral ventilation based on the decrease in concentration.

22. The device described in claim 1, wherein the measuring means is further configured to measure baseline flow rate into the lung compartment.

23. The device described in claim 22, wherein the baseline flow rate into the lung compartment is measured before activation of the unidirectional flow element, and the flow rate into the lung compartment is measured after activation of the unidirectional flow element.

24. The device described in claim 22, wherein the determination means is further configured to determine whether collateral ventilation is occurring within the lung compartment based on the measured baseline flow rate and the measured flow rate into the lung compartment.

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